Randomized Control Trials of Surgery for Pediatric OSA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2019-03-31

Brief Summary

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Randomized study on pediatric OSA with 2 groups: mild-moderate OSA and severe OSA. Mild-moderate are randomized to either expectancy or ATE. Severe are randomized to either ATE or APP. Pediatric age span of 2 until 4,9 years.

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Detailed Description

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Children who are referred to ENT clinic because of sleep-disordered breathing and fulfil the inclusion criteria undergo polysomnography (PSG) and fill in questionnaires. Depending on the outcome of the PSG, whether a) the child have mild to moderate OSA (AHI between 2-9.9) the family is asked to be in the study. If yes, the doctor take a sealed envelope and open it, either the child are randomized to adenotonsillectomy (ATE) or 6 months expectancy. Whether PSG shows b) severe OSA and the family accept participation the child is operated within a month. There is a straification beetween 2 groups, if AHI is 1) between 10 and 29.9 or 2) above 30. A sealed envelope is open in the operating room by the surgeon. The child is randomized to either ATE or ATE and suturing of the tonsillar pillars. The study is blinded for the family, who will not know which method the child has undergone. After 6 months all children will undergo follow-up with PSG and questionnaires. If the expectancy group will deteriorate during waiting time, or the child still has moderate to severe OSA, they will undergo ATE. Further follow-ups at three and ten years. Altogether 160 children should be evaluated with two PSG, 80 in each group.

Conditions

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Sleep Apnea, Obstructive Otorhinolaryngologic Diseases Pediatric Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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expectancy for mild-moderate OSA

6 months expectancy

Group Type NO_INTERVENTION

No interventions assigned to this group

ATE for mild-moderate OSA

adeno-tonsillectomy

Group Type EXPERIMENTAL

ATE

Intervention Type PROCEDURE

surgical removal of adenoids and tonsils

ATE for severe OSA

adeno-tonsillectomy

Group Type EXPERIMENTAL

ATE

Intervention Type PROCEDURE

surgical removal of adenoids and tonsils

APP for severe OSA

adeno-pharyngoplasty

Group Type EXPERIMENTAL

APP

Intervention Type PROCEDURE

surgical removal of adenoids and tonsils and suturing of palatal pillars

Interventions

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ATE

surgical removal of adenoids and tonsils

Intervention Type PROCEDURE

APP

surgical removal of adenoids and tonsils and suturing of palatal pillars

Intervention Type PROCEDURE

Other Intervention Names

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adeno-tonsillectomy adeno-pharyngoplasty

Eligibility Criteria

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Inclusion Criteria

* OAHI \>= 2
* Tonsillary hypertrophy, Brodsky size 2-4
* Adequate swedish knowledge

Exclusion Criteria

* Cardiovascular disorders
* Pulmonary disorders
* Neuromuscular disorders
* Cranoifacial malformations
* Genetic disorders
* Earlier performed adenoid-tonsillary-surgery
* Bleeding disorders

Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No